Headstrong Intervention for Recurrent Pediatric Headache
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- Pain, mood, and stress self-rating scales
研究概览
简要总结
Purpose of this study is to determine if a CD-ROM computer program (called "Headstrong") is effective in helping children cope with chronic headaches.
详细描述
Children, 7-12 years, with recurrent headaches are randomly assigned to an educational CD-ROM program or the Headstrong CD-ROM program. We anticipate that those assigned to the active (Headstrong) program group will have significantly greater reductions in headache frequency, duration, and severity and improvements in mood and quality of life.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 7 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •7-12 years of age
- •having recurrent, intermittent, nonmalignant headaches occurring on an average of at least once per week by parental or child report and separated by symptom-free periods
- •having a diagnosis by a nurse practitioner, pediatrician, or pediatric neurologist of migraine, muscle-contraction, or chronic daily headaches
排除标准
- •their medical history and/or neurological exam suggests that headaches are secondary to another physical or developmental condition
- •their parents report they have been diagnosed with a mental health condition or they are receiving concurrent psychotherapy
- •their baseline headache diaries indicate an average headache frequency of less than one per week
研究组 & 干预措施
1
Educational CD-Rom
干预措施: Educational CD-rom (Other)
2
Headstrong CD-rom
干预措施: Headstrong CD-rom (Other)
结局指标
主要结局
Pain, mood, and stress self-rating scales
时间窗: Baseline, Immediate Post-Treatment and 3, 6 and 12 Month Follow-Up
次要结局
- Headache-related disability(Baseline, Immediate Post-Treatment and 3, 6 and 12 Month Follow-Up)
- Quality of life(Baseline, Immediate Post-Treatment and 3, 6 and 12 Month Follow-Up)
研究者
Michael Rapoff, Ph.D.
Professor
University of Kansas Medical Center